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This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib was supplied as tablets in the retail product Tarceva. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Baseline to the end of the study (up to 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response | Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | 9300 | Belgium | ||||
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Total of 59 patients were screened at 17 specialist oncology and pneumology centers in Belgium, 57 of which started Tarceva therapy as second-line treatment and constitute safety analysis (SA) population. Three patients violated the protocol, leaving 54 patients in the per-protocol (PP) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib | Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline to the end of the study (up to 2 years) |
| Overall Survival | Overall survival was defined as the time from Baseline until death from any cause. | Up to 2 years |
| Percentage of Participants Who Developed Rash | Up to 2 years |
| Percentage of Participants Who Developed Diarrhea | Up to 2 years |
| Antwerp |
| 2020 |
| Belgium |
| Boussu | 7360 | Belgium |
| Brussels | 1200 | Belgium |
| Charleroi | 6000 | Belgium |
| Dendermonde | 9200 | Belgium |
| Duffel | 2570 | Belgium |
| Edegem | 2650 | Belgium |
| Frameries | 7080 | Belgium |
| Genk | 3600 | Belgium |
| Gilly | 6060 | Belgium |
| Gosselies | 6041 | Belgium |
| Liège | 4000 | Belgium |
| Mons | 7000 | Belgium |
| Montegnée | 4420 | Belgium |
| Namur | 5000 | Belgium |
| Ottignies | 1340 | Belgium |
| Roeselare | 8800 | Belgium |
| Sint-Niklaas | 9100 | Belgium |
| Tournai | 7500 | Belgium |
| Turnhout | 2300 | Belgium |
| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population is represented as the per protocol population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib | Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. | Posted | Median | 95% Confidence Interval | Months | Baseline to the end of the study (up to 2 years) |
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| Secondary | Best Overall Response | Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. | Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis. | Posted | Number | 97.5% Confidence Interval | Percentage of participants | Baseline to the end of the study (up to 2 years) |
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| Secondary | Overall Survival | Overall survival was defined as the time from Baseline until death from any cause. | Posted | Median | 95% Confidence Interval | months | Up to 2 years |
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| Secondary | Percentage of Participants Who Developed Rash | Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
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| Secondary | Percentage of Participants Who Developed Diarrhea | Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 2 years |
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Time frame is up to 2 years
Safety analysis population: All participants who received at least 1 dose of erlotinib.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erlotinib | Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg. | 17 | 57 | 51 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| C-reactive protein increase | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Procalcitonin increased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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| Conjunctivities | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
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